The following data is part of a premarket notification filed by Biomedics with the FDA for The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K980983 |
| 510k Number | K980983 |
| Device Name: | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
| Classification | Plate, Bone |
| Applicant | BIOMEDICS 536 SOUTH RIMPAU BLVD. Los Angeles, CA 90020 |
| Contact | Carol E Jones |
| Correspondent | Carol E Jones BIOMEDICS 536 SOUTH RIMPAU BLVD. Los Angeles, CA 90020 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3848120361 | K980983 | 000 |
| M3848130401 | K980983 | 000 |
| M384813040US1 | K980983 | 000 |
| M3848130411 | K980983 | 000 |
| M384813041US1 | K980983 | 000 |
| M3848130421 | K980983 | 000 |
| M384813042US1 | K980983 | 000 |
| M3848130490 | K980983 | 000 |
| M3848130500 | K980983 | 000 |
| M384813050CP1 | K980983 | 000 |
| M384813050US0 | K980983 | 000 |
| M3848130391 | K980983 | 000 |
| M384813038US1 | K980983 | 000 |
| M3848130110 | K980983 | 000 |
| M3848130120 | K980983 | 000 |
| M3848130130 | K980983 | 000 |
| M3848130140 | K980983 | 000 |
| M3848130150 | K980983 | 000 |
| M3848130160 | K980983 | 000 |
| M3848130190 | K980983 | 000 |
| M3848130371 | K980983 | 000 |
| M384813037US1 | K980983 | 000 |
| M3848130381 | K980983 | 000 |
| M3848130510 | K980983 | 000 |
| M3848130520 | K980983 | 000 |
| M3848130530 | K980983 | 000 |
| M384812053CP1 | K980983 | 000 |
| M384812053US0 | K980983 | 000 |
| M3848120540 | K980983 | 000 |
| M384812054CP1 | K980983 | 000 |
| M384812054US0 | K980983 | 000 |
| M3848131800 | K980983 | 000 |
| M384813180CP1 | K980983 | 000 |
| M384813180US0 | K980983 | 000 |
| M3848131810 | K980983 | 000 |
| M384813181CP1 | K980983 | 000 |
| M3848120530 | K980983 | 000 |
| M384812047US0 | K980983 | 000 |
| M384813053CP1 | K980983 | 000 |
| M3848130540 | K980983 | 000 |
| M384813054CP1 | K980983 | 000 |
| M384813054US0 | K980983 | 000 |
| M3848133041 | K980983 | 000 |
| M3848120460 | K980983 | 000 |
| M384812046CP1 | K980983 | 000 |
| M384812046US0 | K980983 | 000 |
| M3848120470 | K980983 | 000 |
| M384812047CP1 | K980983 | 000 |
| M384813181US0 | K980983 | 000 |